Radiochemist

Job Description – Contract Radiochemist (Radiolabeling Support)

Contract Term: 6 months initial project

Location: Massachusetts (on-site role)

Position Summary

We are seeking a contract Radiochemist to support radiolabeling activities in our CMO operations. The candidate will play a key role in technical transfer, process validation, and execution of radiolabeling projects in a GMP environment. This role requires hands-on experience in radiochemistry and the ability to apply USP and cGMP requirements to ensure compliant, high-quality production.

Key Responsibilities

• Execute and support radiolabeling campaigns for client projects, including small molecules, peptides, or biologics.
• Lead and actively participate in technical transfer and process validation activities for incoming CMO projects.
• Evaluate CMO project proposals on technical feasibility and recommend solutions.
• Support manufacturing scheduling and preparation of GMP suites for radiolabeling runs.
• Apply knowledge of USP chapters (e.g., <825>) and 21 CFR 211 requirements to support GMP operations.
• Collaborate with QA/QC, vendors, and project management to ensure readiness and timely delivery.
• Maintain accurate and compliant documentation (batch records, technical reports, change controls).
• Ensure safe use, handling, and disposal of radioactive materials in compliance with radiation safety requirements.

Key Performance Expectations

• Successful technical transfer and GMP suite readiness for each assigned project.
• Completion of validation runs in line with client and regulatory requirements.
• Delivery of radiolabeled products meeting defined quality specifications.
• Collaboration with operators, QA, and project teams to meet weekly production timelines.

Required Skills & Qualifications

• Education: BS in Chemistry (8+ years), MS (5+ years), or PhD (3+ years) with direct experience in radiochemical synthesis, ideally PET IND radiosynthesis.
• Experience meeting requirements of USP <825> and/or 21 CFR 211.
• Hands-on experience or aptitude for using hot cell manipulators to support radiochemistry operations.
• Demonstrated hands-on experience in radiochemistry, radiosynthesis, and GMP production environments.
• Post-graduate experience in radiochemical synthesis strongly preferred.
• Strong communication, troubleshooting, and organizational skills.
• Ability to work on-site, adapt to project needs, and collaborate across functions.
• Must be able to stand for extended periods and handle routine demands of GMP radiochemistry work.